PMID- 20693273
OWN - NLM
STAT- MEDLINE
DCOM- 20101112
LR  - 20220331
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Linking)
VI  - 69
IP  - 11
DP  - 2010 Nov
TI  - Monitoring adverse events of low-dose glucocorticoid therapy: EULAR 
      recommendations for clinical trials and daily practice.
PG  - 1913-9
LID - 10.1136/ard.2009.124958 [doi]
AB  - OBJECTIVE: To develop recommendations on monitoring for adverse events (AEs) of 
      low-dose glucocorticoid (GC) therapy (</=7.5 mg prednisone or equivalent daily) in 
      clinical trials and daily practice. METHODS: Literature was searched for articles 
      containing information on incidence and monitoring of GC-related AEs using 
      PubMed, EMBASE and Cochrane databases. Second, the authors searched for broad 
      accepted guidelines on the monitoring of certain AEs (eg, WHO guidelines on 
      screening for diabetes). Available data were summarised and discussed among 
      experts (rheumatologists and patients) of the EULAR Task Force to decide which 
      potential AEs should be monitored, how and at which interval. RESULTS: Data on 
      monitoring proved to be scarce; most articles were focused on therapeutic effects 
      of GCs, not on occurrence and monitoring of AEs. Most recommendations had to be 
      based on consensus. Those for clinical trials aimed at getting insights into 
      incidence, prevalence and clinical relevance of AEs to create a comprehensive and 
      valid AE-profile of GC therapy. The set of AEs to monitor is therefore more 
      extensive, and often consists of assessments at baseline and at end of trials. 
      Recommendations for daily practice are meant to protect patients from real 
      dangers, which can be prevented or treated. Standard care monitoring needs NOT be 
      extended for patients on low-dose GC therapy, except for osteoporosis (follow 
      national guidelines), and baseline assessments of ankle edema, fasting blood 
      glucose and risk factors for glaucoma. CONCLUSION: Given the incompleteness of 
      literature data, consensus-based recommendations on monitoring for GC-related AEs 
      were created, separately for daily practice and clinical trials.
FAU - van der Goes, M C
AU  - van der Goes MC
AD  - Department of Rheumatology and Clinical Immunology, University Medical Center 
      Utrecht, The Netherlands. m.c.vandergoes@umcutrecht.nl
FAU - Jacobs, J W G
AU  - Jacobs JW
FAU - Boers, M
AU  - Boers M
FAU - Andrews, T
AU  - Andrews T
FAU - Blom-Bakkers, M A M
AU  - Blom-Bakkers MA
FAU - Buttgereit, F
AU  - Buttgereit F
FAU - Caeyers, N
AU  - Caeyers N
FAU - Cutolo, M
AU  - Cutolo M
FAU - Da Silva, J A P
AU  - Da Silva JA
FAU - Guillevin, L
AU  - Guillevin L
FAU - Kirwan, J R
AU  - Kirwan JR
FAU - Rovensky, J
AU  - Rovensky J
FAU - Severijns, G
AU  - Severijns G
FAU - Webber, S
AU  - Webber S
FAU - Westhovens, R
AU  - Westhovens R
FAU - Bijlsma, J W J
AU  - Bijlsma JW
LA  - eng
PT  - Consensus Development Conference
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100806
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Glucocorticoids)
SB  - IM
MH  - Diabetes Mellitus, Type 2/chemically induced
MH  - Drug Administration Schedule
MH  - Drug Monitoring/*methods/standards
MH  - Evidence-Based Medicine/methods
MH  - Glucocorticoids/administration & dosage/*adverse effects
MH  - Humans
MH  - Hypertension/chemically induced
MH  - Randomized Controlled Trials as Topic/methods
MH  - Rheumatic Diseases/*drug therapy
EDAT- 2010/08/10 06:00
MHDA- 2010/11/13 06:00
CRDT- 2010/08/10 06:00
PHST- 2010/08/10 06:00 [entrez]
PHST- 2010/08/10 06:00 [pubmed]
PHST- 2010/11/13 06:00 [medline]
AID - ard.2009.124958 [pii]
AID - 10.1136/ard.2009.124958 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2010 Nov;69(11):1913-9. doi: 10.1136/ard.2009.124958. Epub 2010 
      Aug 6.